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XXXXXXXXXXXX有限公司质量管理体系管理性文件QUALITYSYSTEMPROCEDURE设备控制程序EquipmentControlProcedure编制日期审核日期批准日期发放范围Distribinionscope局域网维修正常后,由设备责任人进行试机确认,设备维修人员应及时将维修情况包括停机时间大于4小时的,费用大于500元的,需要进行验证的等有关内容详细记录在《设备维修记录》QP040-RE-09上,交设备维修主管备案;同时设备责任人应将故障处理情况记录在《设备日运行记录》QP040-RE-06中如果问题较为复杂严重停机维修时间长到影响生产进度,或要发生大额维修费用去购买部品配件,则由设备使用部门及时上报生.产部直接分管领导处理Intheequipmentrun-timetheoperatorshouldfixhisattentionontheworkingstateandwhenmalfunctionappearsheshouldimmediatelystopheequipmentandreportittothegroupleaderinsteadofdealingwithitalone.ThegroupleaderisinchargeofcompletingtheEquipmentMalfunctionReportQP040-RE-08toinformtheequipmentmanagementteamtoarrangethemaintenance.Thepersoninchargeoftheequipmentshouldverifythebroken-downequipmentbytestingandtherepairingengineersshouldrecordthemaintenancesituationintheEquipmentRepairRecordQP040-RE-09containingthefollowingcontentsthatthedowntimeismorethan4hoursthecostismorethan5Xyuanthemattersneedvalidationetcandsubmittedtotheequipmentmaintenancesupervisor.MeanwhilethepersoninchargeoftheequipmentshouldrecordthemalfunctionintheEquipmentDailyOperationRecordQP040-RE-
06.Relativelycomplicatedtroubles»forexamplehedown-timeissolongthatwillinfluencetheproductionscheduleoritwillcostalargeamountofmoneytopurchasecomponentsshouldbereportedtotheproductiondepartmentmanagerbyheequipmentuserdepartment.在停机维修过程中如涉及设备关键部件需要更换,确认新的关键部件的技术参数是否改变了原有参数及工艺,则由QA确定是否需要进行验证,验证按《验证规程》QR040进行Ifthedown-timemaintenancecontainsthechangeofthecriticalcomponentsQAwilldeterminewhetherthevalidationisneededornottoseeifthenewparametersofthenewcomponentshavechangedtheoriginalparametersandprocesses.ThevalidationwillbecarriedoutaccordingtotheValidationRegulationQR
40.设备检查EquipmentInspection为了保证设备经常处于完好的状态卜.,必须要对一般设备进行口常开机自检及重关设备定期巡检ItisnecessarytoconductadailyPOSTPower-onSelfTestforthegeneralequipmentandpatrolinspectionforthecriticalinspection.一般设备日常检查Dailyinspectionofthegeneralequipment一般设备日常检查由操作者进行设备操作者在进入机器正常工作状态之前必须进行开机自检开机自检的内容主要有设备“完好设备”标识牌和运行状态牌是否完整;开机时是否有异常声音;各操作按钮是否灵敏可靠;与各机械部件连接是否紧固开机自检情况填写在《设备日运行记录》QP040-RE-06上Dailyinspectionofthegeneralequipmentisimplementedbytheoperators.TheequipmentoperatorshouldcarryoutaPOSTPower-onSelfTestbeforethemachinegelsintonormalworkingstatus.ThecontentofaPOSTmainlyincludesthefollowingitemsrespectivelytocheckifthe“GoodEquipment”cardand“Operational”cardarccompletetoseeifthereisanynoisewhenpoweringthemachinetoverifythesensitivityanddependabilityofeachoperationalbuttonandtoensurethattheconnectionofeachcomponentisfastened.ThePOSTPowcr-onSelfTestcircumstanceshouldbecompletedintheEquipmentDailyOperationRecordQP040-RE-
06.重关设备的定期巡检Theperiodicalpatrolinspectionofthecriticalequipment1设备的定期巡检由设备管理组或设备维修人员负责;定期巡检内容根据《重关设备清单与日常巡检内容》QP040-RE-15进行EachequipmentmanagementteamorequipmentmaintenancepersonnelshouldtakechargeoftheperiodicalinspectionofthecriticalequipmentaccordingtotheCriticalEquipmentListandDailyInspectionRecordQP040-RE-
15.2设备管理组负责依照各个部门全年的设备管理计划和目标编写年度设备维护保养计划,再依照所编写的年度设备维护保养计划对定期巡检的情况进行指导和督促检查;Theequipmentmanagementteamshouldbeinchargeofestablishingtheannualmaintenanceplanofheequipmentaccordingtotheannualequipmentmanagementplanandobjectivesofeachdepartmentandthenconductingsupervisingandinspectingtheperiodicalinspectionbasedonheannualplan.3维护保养实施人员在做好定期巡检后,应填写《设备H常巡检记录表》QP040-RE-07AfterheperiodicalinspectionthemaintenancepersonnelshouldcompletetheEquipmentDailyPatrolInspectionRecordQP040-RE-
07.检查时如果发现问题按条处理Ifproblemsarefoundduringtheinspectionitwillbehandledaccordingto
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3.设备调试将设备调整限度和允许公差的说明放在需要定期调试的设备或附近,或者从事这些调试的工作人员都备有说明Instructionsofequipmentadjustinglimitationandallowabletoleranceshouldbeplacedonorbytheequipmentthatneedsregulardebuggingorstockedbythedebuggingpersonnel.
4.5设备定置管理EquipmentFixationManagement设备调拨和移装Equipmentallocationandmoving设备调拨和移装时,设备部负责台帐和标牌更新变动后设备由QA确定是否需要验证,如需验证,按《验证规程》QR040进行,设备应在验证完成后正式启用Whenequipmentallocationandmovingtheaccountsandidentificationsupdatedbytheequipmentdepartment.QAwilldeterminewhetherthemovedequipmentneedsvalidatingornotifnecessaryitwillbeimplementedaccordingtotheValidationRegulationQR040andtheequipmentshouldbeusedafterthevalidation.设备封存和启用Equipmentsealingandenabling设备的封存和启用时,设备部负责做好标识,同时进行台帐更新;启封使用的设备由QA确定是否需要进行验证,如需验证,按《验证规程》QR040进行,设备应在验证完成后正式启用Whenequipmentsealingandenablingtheidentificationspreparedandlistupdatedbytheequipmentdepartment.QAshoulddeterminewhetherthevalidationisneededornotfortheenabledequipmentofnecessaryitwillbeimplementedaccordingtotheValidationRegulationQR040andtheequipmentshouldbeusedafterthevalidation.设备的报废Equipmentscrapping为提高生产效率,使设备更能符合生产和发展需要,必须对一些设备进行报废更新设备的报废申请由使用部门提出,申请提出必须符合设备报废更新原则Ilisnecessarytoscrapandrenewsomeequipmentwiththepurposeofenhancingproductivityandmakingtheequipmentmoreconsistentwiththedevelopingrequirements.Equipmentscrappingshouldbeproposedbytheuserdepartmentandapplicabletothescrappingandupdatingprinciple.报废更新原则ScrappingandupdatingprinciplesI主要结构陈旧、精度低劣,生产率低不能改装利用者;Theequipmentwhosemainstructureisoldprecisionisinferiorproductivityislowandmodificationisimpossible;2不能迁移的设备,因厂房改建与工艺布置改变必须拆毁者;Theequipmentthatcantbemovedandmustbedemolishedresultingfromworkshoprebuildingandprocesschange;3腐蚀过甚,无修复价值或继续使用易发生危险者;TheequipmentthathasbeencoiTodedtoomuchhasnorepairingvaluesoriseasytocauserisksifusedcontinuously;4绝缘老化、性能低劣,无修复价值;Theequipmentwhoseinsulationisagedandperformanceisbadwithoutanyrepairingvalues;5因事故或其它灾害使设备遭受严重损坏,无修复价值者Theequipmentthathasbeenbadlydamagedduetoaccidentorotherdisasterswithoutanyrepairingvalues
453.3报废的设备应在显著位置加以标识Thescrappedequipmentshouldbemarkedinaprominentposition.
453.4重要关键设备和一般设备报废按《固定资产管理制度》AFN003进行二ThescrappingofcriticalequipmentandgeneralequipmentshouldbeimplementedaccordingtotheFix-assertsManagementSystemAFN
003.低值易耗设备的报废,由使用部门填写《低值易耗设备报废申请单》QP040-RE-14签批后进行Thescrappingoflow-valueconsumablesshouldberecordedintheLow-valueConsumablesScrappingRequestandapprovedbyrelevantprincipalswithsignatures.相关文件RelevantDocuments《验证规程》ValidationRegulationQR040记录Records《新工艺装备申请单》ApplicationFormforNewProcessEquipmentQP040-RE-01《设备开箱检查记录》EquipmentOpen-packageInspectionRecordQP040-RE-02《设备安装调试过程报告单》EquipmentInstallationDebuggingReportQP040-RE-03《设备定人定机表》CertainPersonsforCertainEquipmentListQP040-RE-05《设备日运行记录》EquipmentDailyOperationRecordQP040-RE-06《设备日常巡检记录表》EquipmentDailyPatrolInspectionRecordQP040-RE-07《设备故障报告单》EquipmentMalfunctionReportQP040-RE-08《设备维修记录》EquipmentRepairRecordQP040-RE-09《设备台帐》EquipmentAccountQP040-RE-10《设备保养记录》EquipmentMaintenanceRecordQP040-RE-11《设备清洁记录》EquipmentCleaningRecordQP040-RE-13《低值易耗设备报废申请单》Low-valueConsumablesScrappingRequestQP040-RE-14《重关设备清单与H常巡检内容》CriticalEquipmentListandDailyInspectionRecordQP040-RE-15文件更改履历DocumentHistorySummary目录CONTENT序号名称页码NumberTitlePage目的PURPOSE2适用范围SCOPE2职责RESPONSIBILITIES2设备的控制THEEQUIPMENTCONTROL3相关文件RELEVANTDOCUMENTS11记录RECORDS11文件更改履历DOCUMENTHISTORYSUMMARY
12.目的Purpose加强设备管理,使其在合适的状态下工作,确保不影响产品质最Thepurposethisprocedureistostrengthentheequipmentmanagementmakingtheequipmentoperateinanappropriatestateandensuringthattheequipmentwillnothavebadeffectontheproducts..适用范围Scope本公司各种产品生产所涉及的全部设备及实验设备TheprocedureisapplicabletoallthecompanysmanufacturingequipmentandRDfacilities..职责Responsibilities设备管理组职责Theresponsibilitiesoftheequipmentmanagementteamsshouldincludethefollowingaspects:负责制订全年的设备管理计划和目标,并组织实施管理Establishannualequipmentmanagementplansandobjectivesaswellasorganizeandimplementthemanagement.负责设备的状态进行分析,掌握设备技术状态Analyzeandmastertheequipmenttechnicalstate.负责设备档案的汇集和设备台帐的建立.Takechargeofcollectingequipmentfilesandestablishingequipmentlist.负责组织设备引进方案的调研、论证,统筹设备的选型、安装调试、维修保养、改进更新等Takechargeoforganizingtheinvestigationanddemonstrationoftheequipmentintroducingplanandcoordinatingtheequipmenttype-selectioninstallationmaintenanceimprovementetc.负责设备的改进,验收.Improveandaccepttheequipment.负责设备验证的IQ、OQ工作TakechargeofIQandOQ.负责参与新设备的采购Engageinthepurchasingofnewequipment.生产技术部职责TheresponsibilitiesofManufacturingTechniquescontainthefollowingitems.负责新产品、新工艺相关的设备引进工作的规划方案的工艺评审工作和参数确认工作Processreviewandparameterconfirmationoftheintroductionplanontheequipmentrelatedtonewproductsandprocesses.负责设备的PQ验证EquipmentsPQ.采购部职责TheresponsibilitiesofPurchasingDepartmentshouldcoverthefollowingaspects.负责新设备的采购管理工作Takechargeofthepurchasingmanagementofnewequipment.采购负责联系新购设备供应商进行调试并协助设备管理组进行保修服务Communicatingwiththesupplierofthenew-purchasedequipmentoptimizetheequipmentdebuggingandcoordinatewiththeEquipmentManagementTeamstocarryouttheequipmentwarrantyservice.QA部职责TheresponsibilitiesofQAincludethefollowingitem.负责设备验证的管理工作Managetheequipmentvalidation.设备使用部门职责Theresponsibilitiesofthedepartmentsthatusetheequipmentareasfollows.负责本部门设备口常维护保养实施及配合进行定期保养工作Implementthedailymaintenanceoftheequipmentandcooperatewithotherdepartmentstocarryouttheperiodicalmaintenance负责组织培训工作Organizerelevanttrainings设备的控制TheEquipmentControl设备管理计划和目标的制定和实施Establishingandimplementingtheequipmentmanagementplansandobjectives每年初,设备管理组按前一年度的运营情况以及本年度规划,制订出“设备年度保养计划”,分解成每月的定期维护保养内容由设备管理组及设备使用部门制定本年度“设备年度添置计划”、“备品备件年度添置计划”等计划和目标每月分解后实施AtthebeginningofeachyeartheequipmentmanagementteamineachProductionDepartmentdrawsuptheAnnualEquipmentMaintenancePlanwhichcanberesolvedintomonthlymaintenanceitemsaccordingtothecompanysdivisionsthelastyearsbusinessstateandthecurrentyearsplan.Annualplansandobjectivesas“AnnualEquipmentAdditionPlan”,“AnnualEquipmentBackupPlan”etc.shallbeestablishedandimplementedaftermonthlyarrangementbytheequipmentanddeviceusingdepartment.设备前期管理Theequipmentprophasemanagement设备购置申请Theequipmentpurchasingrequest设备申购由使用部门提出,并填写采购申请单Thesubscriptionofheequipmentisproposedbytheequipmentmanagementteamoftheuserdepartment.Andfillinthepurchaseapplicationform.设备选型Thetype-selectionoftheequipment设备管理组依据符合生产要求,易于清洗、消毒,便于生产操作和维修、保养,并能防止差错和减少污染的原则协助生产部提出确定机型、生产厂家供采购部参考;经过适当设计、建造、放置和安装的新设备,要利于保养、调试、清洁和使用;UndertheprincipleofbeingconsistentwithmanufacturingrequirementsbeingeasytocleansterilizeandmaintainaswellaspreventingerrorsandreducingpollutiontheequipmentmanagementteamscoordinatingwithProductionDepartmentspresenttheconfirmedtypeandmanufacturerforPurchasingDepartmentsreference.Thenewequipmentbyappropriatedesignconstructionplacementandinstallationshouldbeeasytomaintaindebugcleananduse.新产品、新工艺相关设备的引进,由设备管理组会同相关部门进行调研,经过技术经济水平论证后,确定型号订货设备管理组负责将应征验证合格的新设备增补到定期维护保养计划内容中ThetypeandorderoftheintroducingequipmentrelatedtonewproductsandprocessesshouldbedeterminedaftertheinvestigationofEquipmentDevelopmentDepartmentandotherrelevantdepartmentsaswellastheacquisitionoftechnicalandeconomicaldemonstration.设备采购Theequipmentpurchasing采购部根据审批后的申请单以及选型资料落实采购工作,签订合同时下列技术要素将做为合同条款的•部分PurchasingDepartmentimplementsthepurchasingaccordingtotheapprovedrequestandtype-selectioninformation.Thefollowingtechnicalfactorswillberegardedaspartsofthepurchasingcontract.技术协议必须包括下列要素设备名称、数量、产地设备应是全新的,并附有产地证明和合格证主要技术性能指标交货日期、安装和调试质量索赔条款明确验收标准和验收方式明确保修期和包后服务要求技术协议必须与商务合同同时生效必要时,明确培训计划和要求,以及技术文件要求Technicalcontractshallincludebelowfactors:Namequantityandoriginoftheequipment;Theequipmentshouldbenewandattachedwithcertificateoforiginandcertification;Majortechnicalindicators;Deliverydateinstallationanddebugging;Qualityclaimclauses;Acceptancestandardsandmanners;Warrantyandafter-salesservicerequirement;Thetechnicalcontractshouldbeeffectivewiththebusinesscontract;Thetrainingplanandrequirementaswellastechnicaldocumentsshouldbeidentifiedifnecessary.设备验收Theequipmentacceptance.
4.1设备到公司后采购人员通知设备管理组到场验收,设备管理组根据设备装箱单和合同进行开箱检查和清点工作设备开箱后,由使用部门根据设备的布置情况把设备放置到相应地点Aftertheequipmentdeliveredtothecompanythepurchasingpersonnelshouldinformtheequipmentmanagementteamofrelevantdepartmentstocheckandcountheequipmentaccordingtotheequipmentpackinglistandcontact.A.2验收后,对于重要关键设备,设备管理组依据开箱情况填写《设备开箱检查记录》QP040-RE-02如实记录设备验收情况,做出符合性判断对不符合要求的由采购部负责退货或调换确认符合要求的设备可实施安装、调试其余一般设备和低值易耗设备只做简单验收,如合格即可直接移交使用部门,并填写《设备开箱检查记录》QP040-RE-02AftertheequipmentacceptancetheunpackingstatusofthecriticalequipmentshouldberecordedintheEquipmentOpen-packageInspectionRecordQP040-RE-02andtheconformitiesoftheequipmentshouldbejudged.TheequipmentfallstobeconsistentwiththerequirementshouldbereturnedorexchangedbyPurchasingDepartmentwhiletheconformingequipmentwillbeinstalledanddebugged.Thegeneralequipmentandlow-valueconsumableswillonlycarryoutasimpleacceptanceandwillbehandledtotheusedepartmentwithacompletedEquipmentOpen-packageInspectionRecordQP040-RE-02ifapproved.设备安装调试Theequipmentinstallationanddebugging设备安装由设备管理组组织人员进行,相关的部门协助设备安装开展工作Theequipmentmanagementteamcoordinatingwithrelevantdepartmentsshouldtakechargeoftheequipmentinstallation.设备安装到位后,由设备管理组负货做“调试中设备”标识并组织进行调试;AftertheequipmentinstalledtheequipmentmanagementteamshouldaffixtheDebuggingEquipment”andorganizedebugging.调试认为运行不正常或不符合要求,应由采购部负责退货、调换或联系制造厂进行维修;AfterthedebuggingtheimproperlyoperatingorunqualifiedequipmentshouldbereturnedorexchangedtothemanufacturerbyPurchasingDepartment.AlsoPurchasingDepartmentcancommunicatethemanufacturertorepairtheequipment.
4.
25.4对自制设备,在设备开发前,需求部门应提出开发需求、技术参数要求、工艺要求和验收标准,以便在设备制成后,设备开发部门应提供完善的技术资料由设备管理组会同使用部门技术人员、工艺人员进行自制新设备的安装调试,调试中认为运行不正常或不符合要求应退回设备开发部门进行改进Beforethedevelopmentofself-designedequipmenteachdemanddepiirtmentshouldproposedevelopingrequirementslechnicalparameterrequiiieinenlsprocessrequirementsandacceptancestandardsaccordingtotheproductrequirementsothattheequipmentdevelopingdepartmentcanprovideperfectdataaftertheachievementoftheequipment.Thecquipnicntmanagementteamtogetherwitlithetechnicalpersonnelandprocesspersonneloftheuserdepartmentshouldinstalluiddebugthenewequipmentandreturnimproperlyoperatingorunqualifiedequipmentoheequipmentdevelopingdepartmenioimplementtheimprovement.调试正常后,可移交使用部门对过程特别复杂的重关设备还必须填写《设备安装调试过程报告单》QP040-RE-03o当移交使用部门后,使用部门通知QA部门,由设备使用部门与QA部门共同商议是否需要对该设备进行验证如需验证,验证依照《验证规程》QR040进行,验证合格则投入使用,否则退回采购部处理;如不需验证,则可直接投入使用AfterdebuggednormallytheusedepartmentshallfilltheEquipmentInstallationDebuggingReportQP040-RE-03forcomplicatedequipmenttheusedepartmenwillsendrelatedequipmentinformationtoQAandthentheusedepartmentandQAtogetherdeterminewhetherthevalidationwillbecarriedout.IfyesthevalidationshallbecarriedoutaccordingtotheValidationRegulationQR040equipmentcantbeusedunlessthevalidationisqualifiedoritshallbereturnedtoPurchaseDepartmenttohandle.Ifnotheequipmentcanbeuseddirectly.设备管理组根据设备的价值和/或对产品性能影响的重要性,将设备分为“重要关键设备”简称“重关设备”、“一般设备”和“低值易耗设备”三级,实行分级管理1重关设备对产品性能影响重要或价值高昂的设备一般设备价值大于2000元或对产品性能影响一般的设备3低值易耗设备价值低于2000元且对产品性能影响很小的设备Basedontheequipmentsvalueandorimportancetotheproductperformancetheequipmentmanagementteamclassifiestheequipmentintothreecategoriesnamely4tCriticalEquipment”GeneralEquipmcnt^^and“Low-valueConsumablesandmanagethemaccordingtotheirgrades.Criticalequipmentmeanstheequipmentthatwillhaveimportanteffectontheproductsorisvaluable;Generalequipmentmeanstheequipmentthatcostsmorethan2000yuanorwillaffecttheproductperformancegenerally;Low-valueconsumablesmeantheequipmentthatcostlessthan2000yuanandwillhardlyinfluenceheproductperformance.
4.
2.7设备管理组负责制定一般设备和重关设备的设备操作维护规程TheequipmentmanagementteamshouldestablishSOPsofthegeneralequipmentandthecriticalequipment.设备档案管理EquipmentArchivesManagement设备台账EquipmentAccount设备管理组负责建立《设备台帐》QP040-RE-10《设备台帐》QP040-RE-10根据实际情况随时更新;对于重关设备和一般设备,设备管理组在设备管理中应做到帐、卡、物相符TheequipmentmanagementteamshouldberesponsibleforestablishingandupdatingtheEquipmentAccountQP040-RE-10basedontheactualsituation.Forthecriticalequipmentandthegeneralequipmenttheequipmentmanagementteamshouldensureconsistencyofaccountscardsandobjects.设备办理验收手续移交使用部门后,设备管理组应负责设定设备编号,并在设备的明显位置贴上“完好设备”卡设备编号采用四节编号法大类号、分类号、型别号、公司内顺序号,具体参照附页设备分类附表Aftertheequipmentacceptedanddeliveredtotheuserdepartmenttheequipmentmanagementteamshouldtakechargeofsettingtheequipmentnumberandaffixingthe“GoodEquipment“cardintheobviouslocationoftheequipment.Theequipmentisintheemployofa“fbur-part“numberingmannernamelycategorynumberclassificationnumbertypenumberandserialnumberofhecompanywhichisdetaileddescribedintheattachedsheetcalledEquipmentClassificationSchedule.设备管理组负责对“重关设备”、“待修设备”、“封存设备”等进行标识并检查Theequipmentmanagementteamisresponsibleloridentifyingandcheckingthecriticalequipmenttheequipmenttoberepairedthestoredequipmentetc.设备管理组对列入固定资产的设备建立档案,对设备的技术资料等进行统•管理Theequipmentmanagementteamshouldestablishrecordsfortheequipmentthathasbeenenrolledasfixed-assertsandmanagethetechnicaldataofheequipment.设备的使用和维护管理Theuseandmaintenancemanagementoftheequipment设备的日常使用Thedailyuseoftheequipment对设备操作者的要求Theoperationalrequirementsoftheequipment1新工人在使用设备前或操作者使用新购设备,必须经设备管理组对其进行一定时间的该设备安全生产有关的上岗培训和设备操作培训,考核合格后方可上岗独立操作;Theequipmentmanagementteamshouldorganizepre-posttrainingsandequipmentoperationtrainingsrelatedosafetyforthenewemployees.Thenewemployeesmustbetrainedbeforeusingoroperatingthenewpurchasedequipmentandtheycanonlyindependentlyoperatetheequipmentafterexaminedqualified.2公司内部工种调动的操作者,须进行上岗培训后方可上岗独立操作;Theoperatorwhochangeshisjobswithinthecompanyshouldreceivejobtrainingbeforeindependentlyoperatingtheequipment.3设备操作者应基本掌握设备的“三好”管好、用好、保养好、“四言‘会使用、会保养、会检查、会调整Theequipmentoperatorshouldbasicallymasterthefollowingitemsliterallyuthrcc-goodsmakingtheequipmentmanagedusedandmaintainedperfectlyand“four-abilities“equippedwithfourabilitiesnamelyusemaintenanceinspectionandadjustment.设备的定人定机Certainpersonsforcertainequipment1属于“重关设备”,由各使用部门提出定人定机的初步名单,经设备管理组审核后实施Thecertainpersonsforhecriticalequipmentshouldbeproposedbytheuserdepartmentandimplementedbytheequipmentmanagementteamsreview.2属于“一般设备”,由各使用部门根据实际情况实施定人定机Thecertainpersonsforthegeneralequipmentwillbecarriedoutbyeachuserdepartmentbasedonactualsituation.3正常情况下,操作者不得串机使用;Normallytheoperatorisnotallowedtooperatedifferentequipmentatthesametime.4属多人操作的设备,由使用部门指定专人负责保管与维护保养Theequipmentthatneedsmorethanonepersontooperateshouldbemanagedandmaintainedbycertainpersonsappointedbytheuserdepartment.设备操作人员必须严格按照设备操作维护规程使用设备,一般设备和重关设备责任人应将每天设备运行时间、运行状况记录在《设备日运行记录》QP040-RE-06上TheequipmentoperatormustusetheequipmentstrictlyaccordingtotheequipmentSOPs.ThepersoninchargeofthegeneralequipmentandthecriticalequipmentshouldrecordtheequipmentdailyoperationaltimeandstateontheEquipmentDailyOperationRecordQP040-RE-
06.设备的维护与保养Theequipmentmaintenance设备管理组建立并保持调试,清洁和保养的设备计划表,以保证达到生产规范Theequipmentmanagementteamshouldestablishandkeeptheequipmentdebuggingcleanlinessandmaintenanceschedulestoensureregularmanufacturing.设备的维护保养主要由操作者和维修人员负责完成,内容包括口常保养和定期保养Theoperatortogetherwiththemaintenancepersonnelshouldbeinchargeoftheequipmentmaintenancecoveringdailymaintenanceandperiodicalmaintenance.1日常保养由操作者负责完成保养内容设备操作规程中相关内容;保持设备的整洁;前段需清洗设备清洗完后并填写《设备清洁记录》QP040-RE-13重点是对常用部件的性能、参数、运行条件进行确认,和对设备外表面的清洁卫生处理TheoperatorshouldtakechargeofdailymaintenancewhichincludesthefollowingaspectsnamelyrelevantmattersrequiredintheSOPstheequipmentincleanandtidyconditionandcompletingtheEquipmentCleaningRecordQP040-RE-13oftheequipmentthatneedsfront-endcleaningafterthecleaningfinished.Thekeypointhereisthatverifyingheperformanceparametersandoperationalconditionofthecommonpartsandcleaningthesurfaceoftheequipment.2定期保养以维修人员为主、操作者配合、设备管理员指导对重关设备和一般设备进行定期保养对长期使用后产生的性能漂移、参数改变、元器件老化等现象进行现场及时妥善处理或有计划的更换,时运动机件进行有效的润滑和去污垢,对磨损的部件进行及时更换以免隐患变成故障,完成保养后填写《设备保养QP040-RE-lloPeriodicalmaintenanceisdirectedbythemaintenancepersonnelcoordinatedwiththeoperatorundertheguidanceoftheequipmentmanager.Thecriticalequipmentandhegeneralequipmentshouldbemaintainedperiodically.Suchphenomenaasperformancefluctuationparameterchangingcomponentagingetc.afterlong-termuseshouldbeproperlydealtwithbyhesiteorchangedaccordingtoplans.Movingpartsshouldbelubricatedanddecontaminatedeffectively.Whileworncomponentsshouldbechangedimmediatelyincasethathiddentroublesturnintomalfunctions.TheEquipmentMaintenanceRecordQP040-RE-11willbecompletedafterallthemaintenancework.3《设备保养记录表QP040-RE-11的No.由8位阿拉伯数字组成从左往右,前2位是设备所在部门的部代码;第3到第6位是保养发生时所在的年月;第7和第8位是流水号,从01到99ThenumberoftheEquipmentMaintenanceRecordQP040-RE-11ismadeupof8Arabicnumeralsfromleftorighttheformerfouristhecodeoftheuserdepartmentthefifthandsixthnumbersstandforthemonthwhenthemaintenanceiscarriedoutandthelasttworepresenttheserialnumberfrom01to
99.4保养依据设备操作规程中相关内容TherelevantcontentinSOPsshouidberegardedasthemaintenancebasis.5保养周期重关设备每6个月进行一次,一般设备每12个月进行一次Themaintenanceperiodisregulatedasthefollowingclausethatthecriticalequipmentwillbemaintainedevery6monthsandthegeneralequipmenteveiy12months.6两次保养之间的间隔须严格按照年度设备维护保养计划执行,如未能按时保养,请在《设备保养记录表》QP040-RE-11上详细记录“未能按时保养”的原因和因此产生的后果在维护和保养过程中如涉及设备关键部件更改牵扯到技术参数改变或工艺条件改变的维护保养或技术工艺改进升级性维护,则由QA确定是否需要进行验证,验证按《验证规程》QR040进行Duringtheintenalbetweenthelastandthenextmaintenancerelevantmaintainingworkmustbestrictlycarriedoutaccordingtotheannualequipmentmaintenanceplan.Ifnotthereasonandresultof44notmaintainingonschcdulcshouldberecordedintheEquipmentMaintenanceRecordQP040-RE-
11.IfthemaintenancecontainsthechangeofthecriticalcomponentsinvolvinghemaintenanceoftechnicalparameterchangesorprocesschangesorupgrademaintenanceoftechnicalprocessimprovementthenQAwilldeterminewhetherthevalidationwillbecarriedoutornotseeQR040ValidationRegulation.设备故障管理EquipmentMalfunctionManagement在设备运行时,操作者应密切注意设备运转情况,发现故障应立即停机,不能自行处理的,应及时报告班组长,由班组长填写《设备故障报告单》QP040-RE-08报告设备管理组,由设备管理组安排维修人员检修文件编号DN QP040版本号Version主管部门Resp.Dept.工程部Engineering发放编号DistributionNo修改后版本或页码修改号UpdatedVersionOrPageRevision更改单编号DCRRef更改概述SummaryofChanges生效日期EffectiveDate。